Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, have evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2024. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the Securities and Exchange Commission. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based on this evaluation, management concluded that our disclosure controls and procedures were effective as of December 31, 2024.
Management ’ s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined effective could provide only reasonable assurance with respect to financial statement preparation and presentation.
Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2024, based on the framework in the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on such evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2024.
The effectiveness of the Company’s internal control over financial reporting as of December 31, 2024 has been audited by Ernst & Young LLP, our independent registered public accounting firm, which also audited our Consolidated Financial Statements included in this Annual Report on Form 10-K, as stated in their report which appears with our accompanying Consolidated Financial Statements.
Changes to the Company ’ s Internal Control Over Financial Reporting
There have been no changes to the Company’s internal control over financial reporting that occurred during quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
During the quarter ended December 31, 2024 , none of our officers or directors adopted or terminated any contract, instruction or written plan for the purchase or sale of securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c) under the Exchange Act or any “non-Rule 10b5 - 1 trading arrangement”, as defined in Item 408 of Regulation S-K.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
Except to the extent included below, the information required in Items 10 (Directors, Executive Officers and Corporate Governance), Item 11 (Executive Compensation), Item 12 (Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters), Item 13 (Certain Relationships and Related Transactions, and Director Independence), and Item 14 (Principal Accounting Fees and Services) is incorporated by reference to the Company’s definitive proxy statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of December 31, 2024.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Code of Ethics
We have adopted a Code of Business Conduct and Ethics. We require all employees, including our principal executive officer, principal financial officer, principal accounting officer and other senior officers and our employee directors, to read and to adhere to the Code of Business Conduct and Ethics in discharging their work-related responsibilities. Employees are required to report any conduct that they believe in good faith to be an actual or apparent violation of the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on our website at http://www.OPKO.com. Any amendment to, or waivers of, the Code of Business Conduct and Ethics will be disclosed on our website promptly following the date of such amendment or waiver.
Insider Trading Policy
We have adopted an Insider Trading Policy which governs the purchase, sale and/or any other dispositions of our securities by the Company and its directors, officers and employees and is reasonably designed to promote compliance with insider trading laws, rules and regulations and applicable exchange listing standards. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
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PART IV.
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
(1)
Exhibits: See Index to Exhibits below.
INDEX TO EXHIBITS
Exhibit
Number
Description
2.1 +
Agreement and Plan of Merger, dated January 28, 2011, by and among CURNA, Inc., KUR, LLC, OPKO Pharmaceuticals, LLC, OPKO CURNA, LLC, and certain individuals named therein, filed with the Company ’ s Quarterly Report on Form 10-Q/A filed with the Securities and Exchange Commission on July 25, 2011, and incorporated herein by reference.
2.2
Agreement and Plan of Merger and Reorganization, dated as of January 14, 2022, by and among the Company, Sema4 Holdings Corp., Orion Merger Sub I, Inc., Orion Merger Sub II, LLC, GeneDx Inc. and GeneDx Holding 2, Inc. , filed with the Company ’ s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 18, 2022, and incorporated herein by reference .
2.3
Agreement and Plan of Merger, dated as of May 9, 2022, by and among the Company, ModeX Therapeutics, Inc., Orca Acquisition Sub, Inc. and Gary J. Nabel, solely in the capacity of a representative of the Stockholders, filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on May 13, 2022, and incorporated herein by reference.
2.4 ++
Asset Purchase Agreement, dated as of March 27, 2024 by and among BioReference Health, LLC, OPKO Health, Inc. and Laboratory Corporation of America Holdings, filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 28, 2024, and incorporated herein by reference.
3.1
Amended and Restated Certificate of Incorporation, as amended , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on November 12 , 2013 for the Company ’ s three-month period ended September 30, 2013, and incorporated herein by reference.
3.2
Amended and Restated Bylaws , filed with the Company ’ s Annual Report on Form 10 ⁃ K filed with the Securities and Exchange Commission on February 18, 2021, and incorporated herein by reference.
3.3
Certificate of Designation of Series D Preferred Stock , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on September 24, 2009, and incorporated herein by reference.
3.4
Amendment to Amended and Restated Certificate of Incorporation , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on June 21, 2019, and incorporated herein by reference .
3.5
Composite Amended and Restated Certificate of Incorporation of OPKO Health, Inc., filed with the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024, and incorporated herein by reference.
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4.1
Indenture, dated January 30, 2013, between OPKO Health, Inc. and Wells Fargo Bank, National Association , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on February 5, 2013, and incorporated herein by reference.
4.2
Base Indenture related to the 4.50% Convertible Senior Notes due 2025, dated as of February 7, 2019, by and between OPKO Health, Inc. and U.S. Bank National Association, as trustee , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on February 7, 2019, and incorporated herein by reference.
4.3
Supplemental Indenture related to the 4.50% Convertible Senior Notes due 2025, dated as of February 7, 2019, by and between OPKO Health, Inc. and U.S. Bank National Association, as trustee , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on February 7, 2019, and incorporated herein by reference.
4.4
Description of Securities , filed with the Company ’ s Annual Report on Form 10 ⁃ K filed with the Securities and Exchange Commission on February 18, 2021, and incorporated herein by reference .
4.5
Indenture, dated January 9, 2024, by and between OPKO Health, Inc. and U.S. Bank Trust Company, National Association, as Trustee, filed with the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 9, 2024, and incorporated herein by reference.
4.6
Form of 3.75% Convertible Senior Note due 2029, incorporated by reference to Exhibit A of the Indenture filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 9, 2024.
10.1
Form of Director Indemnification Agreement , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on August 8, 2008 for the Company ’ s three-month period ended June 30, 2008, and incorporated herein by reference.
10.2
Form of Officer Indemnification Agreement , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on August 8, 2008 for the Company ’ s three-month period ended June 30, 2008, and incorporated herein by reference.
10.3 *
Form of Restricted Share Award Agreement for Directors , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on November 9, 2009 for the Company ’ s three-month period ended September 30, 2009, and incorporated herein by reference.
10.4 +
Exclusive License Agreement by and between TESARO, Inc. and OPKO Health, Inc. dated December 10, 2010, filed with the Company’s Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on July 28, 2011, and incorporated herein by reference.
10.5
OPKO Health, Inc. 2016 Equity Incentive Plan, filed with the Company ’ s Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on March 25, 2016, and incorporated herein by reference.
10.6
Development and License Agreement between OPKO Health, Inc. and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 8, 2016 , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on August 8, 2016 for the Company ’ s three-month period ended June 30, 2016, and incorporated herein by reference.
10.7
Form of 5% Convertible Promissory Note dated February 27, 2018 , filed with the Company ’ s Annual Report on Form 10 ⁃ K filed with the Securities and Exchange Commission on March 1 , 2018, and incorporated herein by reference.
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10.8
Share Lending Agreement, dated February 4, 2019, by and between the OPKO Health, Inc. and Jefferies Capital Services, LLC , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on February 7, 2019, and incorporated herein by reference.
10.9
Amendment to Development and License Agreement between EirGen Pharma Ltd. and Vifor Fresenius Medical Care Renal Pharma Ltd., dated May 5, 2020 , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on July 31, 2020 for the Company ’ s three-month period ended June 30, 2020, and incorporated herein by reference.
10.10
Amended and Restated Development and Commercialization License Agreement by and between Pfizer Inc. and OPKO Ireland Ltd., dated May 12, 2020 , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on July 31, 2020 for the Company ’ s three-month period ended June 30, 2020, and incorporated herein by reference.
10.11
Asset Purchase Agreement, dated June 16, 2021, among EirGen Pharma Limited, Horizon Therapeutics Ireland DAC, and OPKO Health, Inc. (with respect to certain sections) , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on July 29, 2021 for the Company ’ s three-month period ended June 30, 2021, and incorporated herein by reference.
10.12
License Agreement by and among EirGen Pharma Limited and Nicoya Macau Limited, dated June 18, 2021 , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on July 29, 2021 for the Company ’ s three-month period ended June 30, 2021, and incorporated herein by reference.
10.13
Exclusive License Agreement, dated July 6, 2021, by and between OPKO Health, Inc. and CAMP4 Therapeutics Corporation , filed with the Company ’ s Quarterly Report on Form 10 ⁃ Q filed with the Securities and Exchange Commission on July 29, 2021 for the Company ’ s three-month period ended June 30, 2021, and incorporated herein by reference.
10.14
Amended and Restated Credit Agreement, dated August 30, 2021, by and among by and among BioReference Laboratories, Inc., certain of its subsidiaries, and JPMorgan Chase Bank, N.A. , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on September 3, 2021, and incorporated herein by reference .
10.15
Shareholder Agreement, dated January 14, 2022, by and between OPKO Health, Inc. and SEMA4 Holdings Corp. , filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on January 18, 2022, and incorporated herein by reference .
10.16
Lock-up and Voting Agreement, dated as of May 9, 2022, by and among the Company, Dr. Phillip Frost, Dr. Jane Hsiao and Frost Gamma Investments Trust.
10.17
Offer Letter, dated May 9, 2022, by and between the Company and Dr. Zerhouni.
10.18
Offer Letter, dated May 9. 2022, by and between the Company and Dr. Nabel.
10.19
Waiver Under and Amendment No. 1 to Amended and Restated Credit Agreement between BioReference Health, LLC, GeneDx, LLC, the other Subsidiary Borrowers party hereto, the other Loan Parties party hereto, the Lenders party hereto, and JPMorgan Chase Bank, N.A., as the administrative agent for the Lenders, dated April 29, 2022, filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on May 4, 2022, and incorporated herein by reference.
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10.20
Settlement Agreement between United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General of the Department of Health and Human Services, and the Defense Health Agency, acting on behalf of the TRICARE Program, the Commonwealth of Massachusetts, acting through the Medicaid Fraud Division of the Office of Attorney General and on behalf of the Executive Office of Health and Human Services, limited to its role as the single state agency for Medicaid, the State of Connecticut, acting through the Attorney General of the State of Connecticut, BioReference Health, LLC and OPKO Health, Inc., and Jean Marie Crowley, effective July 14, 2022, filed with the Company ’ s Current Report on Form 8 ⁃ K filed with the Securities and Exchange Commission on July 15, 2022, and incorporated herein by reference.
10.21
Form of Amended 5% Convertible Promissory Note dated February 10, 2023 , filed as Exhibit 10.22 filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2023, and incorporated herein by reference.
10.22
Waiver and Amendment No. 2 to the Amended and Restated Credit Agreement, dated June 29, 2023, by and among BioReference Health, LLC, certain of its subsidiaries, and JPMorgan Chase Bank, N.A., filed with the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 3, 2023 for the Company's three-month period ended June 30, 2023, and incorporated herein by reference .
10.23 ++
License and Research Collaboration Agreement by and between ModeX Therapeutics, Inc., OPKO Health, Inc. (with respect to certain sections), and Merck Sharp & Dohme LLC dated March 7, 2023, filed with the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 3, 2023 for the Company's three-month period ended March 31, 2023, and incorporated herein by reference.
10.24 ++
Purchase Agreement, dated January 4, 2024, by and between the Company and J.P. Morgan Securities LLC, as representative of the Initial Purchasers named therein, filed with the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on January 9, 2024, and incorporated herein by reference.
10.25 ++
Convertible Note Purchase Agreement, dated as of January 4, 2024, by and among the Company and certain investors, including Frost Gamma Investments Trust and Jane H. Hsiao, Ph.D., MBA, filed with the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on January 9, 2024, and incorporated herein by reference.
10.26 +++
Note Purchase Agreement dated July 17, 2024 by and among the Company, certain purchasers party thereto, OPKO Biologics Limited, Eirgen Pharma Ltd. and HCR Injection SPV, LLC as agent, filed with the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2024, and incorporated herein by reference.
10.27
Form of Note dated July 17, 2024, filed with the Company's Quarterly Report on Form 10Q filed with the Securities and Exchange Commission on August 7, 2024, and incorporated herein by reference.
19.1 **
OPKO Health, Inc. Related Party Transaction Policy.
21 **
Subsidiaries of the Company.
23.1 **
Consent of Ernst & Young LLP.
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31.1 **
Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
31.2 **
Certification by Adam Logal, Chief Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
32.1 **
Certification by Phillip Frost, Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
32.2 **
Certification by Adam Logal, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
97.1
OPKO Health, Inc. Mandatory Recovery of Compensation Policy filed with the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2024, and incorporated herein by reference.
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
*
Denotes management contract or compensatory plan or arrangement.
**
Filed herewith.
+
Certain confidential material contained in the document has been omitted and filed separately with the Securities and Exchange Commission.
++
Pursuant to Item 601(a)(5) of Regulation S-K, schedules and similar attachments to this exhibit have been omitted because they do not contain information material to an investment or voting decision and such information is not otherwise disclosed in such exhibit. The Company will supplementally provide a copy of any omitted schedule or similar attachment to the U.S. Securities and Exchange Commission or its staff upon request.
+++
Pursuant to Item 601(b)(10)(iv) of Regulation S-K, portions of this exhibit have been omitted because the Company customarily and actually treats the omitted portions as private or confidential, and such portions are not material. The Company will supplementally provide a copy of an unredacted copy of this exhibit to the U.S. Securities and Exchange Commission or its staff upon request.
Item 16. FORM 10-K SUMMARY.
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 3, 2025
OPKO HEALTH, INC.
By:
/s/ Phillip Frost, M.D.
Phillip Frost, M.D.
Chairman of the Board and
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Phillip Frost, M.D.
Chairman of the Board and Chief Executive
March 3, 2025
Phillip Frost, M.D.
Officer
(Principal Executive Officer)
/s/ Jane H. Hsiao, Ph.D., MBA
Vice Chairman and Chief Technical Officer
March 3, 2025
Jane H. Hsiao, Ph.D., MBA
/s/ Elias A. Zerhouni, M.D.
Vice Chairman and President
March 3, 2025
Elias A. Zerhouni, M.D.
/s/ Steven D. Rubin
Director and Executive Vice President –
March 3, 2025
Steven D. Rubin
Administration
/s/ Adam Logal
Senior Vice President, Chief Financial Officer,
March 3, 2025
Adam Logal
Chief Accounting Officer and Treasurer
(Principal Financial Officer)
/s/ Gary J. Nabel, M.D., Ph.D.
Director, Chief Innovation Officer
March 3, 2025
Gary J. Nabel, M.D., Ph.D.
/s/ Richard Krasno, Ph.D.
Director
March 3, 2025
Richard Krasno, Ph.D.
/s/ Prem A. Lachman, M.D.
Director
March 3, 2025
Prem A. Lachman M.D.
/s/ Roger J. Medel, M.D.
Director
March 3, 2025
Roger J. Medel, M.D.
/s/ John A. Paganelli
Director
March 3, 2025
John A. Paganelli
/s/ Richard C. Pfenniger, Jr.
Director
March 3, 2025
Richard C. Pfenniger, Jr.
/s/ Alice Lin-Tsing Yu, M.D., Ph.D.
Director
March 3, 2025
Alice Lin-Tsing Yu, M.D., Ph.D.
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Exhibit Number
Description
19.1
OPKO Health, Inc. Related Party Transaction Policy.
21
Subsidiaries of the Company.
23.1
Consent of Independent Registered Public Accounting Firm.
31.1
Certification by Phillip Frost, Chief Executive Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
31.2
Certification by Adam Logal, Chief Financial Officer, pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
32.1
Certification by Phillip Frost, Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
32.2
Certification by Adam Logal, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 for the year ended December 31, 2024.
Exhibit 101.INS
Inline XBRL Instance Document
Exhibit 101.SCH
Inline XBRL Taxonomy Extension Schema Document
Exhibit 101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
Exhibit 101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
Exhibit 101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
Exhibit 101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
Exhibit 104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
146